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Achieve Life Sciences Announces Cytisine Symposium at the 17th World Conference on Tobacco or Health

BOTHELL, Wash. and VANCOUVER, British Columbia,March. 6, 2018 – – Achieve Life Sciences, Inc. (NASDAQ: ACHV), today announced that the World Conference on Tobacco or Health (WCTOH) will be holding a symposium on cytisine research at this year’s annual conference, March 7-9th in Cape Town, South Africa.

The cytisine symposium titled “Is a Globally Affordable Medication to Treat Tobacco Dependence Achievable? The Case of Cytisine.” will be held on Friday, March 9th at 7:45am. Nancy Rigotti, MD, Professor of Medicine, Harvard Medical School and Director, Tobacco Research and Treatment Center, at Massachusetts General Hospital will chair the symposium. Further to Achieve’s collaboration with the National Institutes of Health (NIH) to advance cytisine research, Dr. David Shurtleff, PhD, Acting Director at the NIH, National Center for Complementary and Integrative Health, will be presenting “An Overview of the Safety Assessment for Regulatory Approval of Cytisine in the U.S.”

Dr. Anthony Clarke, PhD, Chief Scientific Officer of Achieve commented, “Significant clinical development progress has been made recently with completion of a Phase I/II trial. Achieve is focused on commencing Phase 3 clinical trials in mid-2018 and appreciates the contributions from the scientific community in aiding the regulatory approval process for cytisine as a cost-effective smoking cessation treatment.”

Two Phase 3 clinical trials of cytisine have been successfully completed in over 2,000 patients. The TASC Phase 3 trial was a 740 patient, double-blind placebo controlled trial conducted by University College London. The CASCAID trial was a 1,310 patient, single-blind trial comparing cytisine to nicotine replacement therapy. Both trials were published in the New England Journal of Medicine in December 2011 and December 2014 respectively.

About Achieve and CytisineAchieve’s focus is to address the global smoking health epidemic through the development and commercialization of cytisine. Tobacco use is currently the leading cause of preventable death and is responsible for nearly six million deaths annually worldwide[1]. It is estimated that 28.6% of all cancer deaths in the U.S. are attributable to cigarette smoking[2].

Achieve is developing cytisine as a smoking cessation aid. Cytisine is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is an established smoking cessation treatment that has been approved and marketed in Central and Eastern Europe for more than 15 years. It is estimated that over 20 million people have used cytisine to help combat nicotine addiction, including approximately 2,000 patients in Phase 3 clinical trials conducted in Europe and New Zealand. Achieve’s focus is to address the global smoking health epidemic, which is currently the leading cause of preventable death and is responsible for nearly six million people losing their lives annually worldwide. Discussions have been held with FDA and a European regulatory agency to determine the clinical and regulatory pathway towards making cytisine widely available.

Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing of clinical development of cytisine, and the potential benefits of cytisine. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisine may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisine; the risk that cytisine will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.